JP6275121B2 - Sample introduction system - Google Patents

Description

Cross-reference to related applications US Provisional Patent Application No. 61 / 642,820 (filed May 4, 2012) is expressly incorporated herein by reference in its entirety.

Declaration on research and development of government examinations None.

1. The present invention generally relates to sample ports and microfluidic devices and systems and methods of use thereof. More particularly, the present invention relates to systems and methods for introducing a fluid sample into a medical diagnostic analyzer or microfluidic device.

2. BACKGROUND OF THE INVENTION Fluid collection systems include (but are not limited to) microfluidic devices and multi- or single-use medical diagnostic devices such as blood gas, hematology and urine analysis testing devices / systems. This is useful for a variety of applications including, but not limited to, performing chemical, clinical and environmental analysis of chemical or biological samples. Such a device is particularly well suited for the analysis of very small samples and can be produced at a relatively low cost. A microfluidic device typically has an open port for sample introduction, a fluid transfer channel, and may have a reagent storage chamber, a pump, a valve, a filter, and the like.

  In a typical method for introducing a fluid sample into a microfluidic device, the sample was dispensed from an original collection device, such as a syringe, into an open port of the microfluidic device. In some cases, such as when using VACUTAINER®, it is sometimes necessary to first take a portion of the fluid under test from the VACUTAINER by pipette or syringe and then dispense the sample into the open port of the microfluidic device. . Regardless of the exact method used, there is an obvious risk of biological or chemical disaster spills when samples must be dispensed into open ports. Furthermore, the use of a large number of consumables, such as when using the VACUTAINER described above, often requires exposure, which increases the risk of exposure and is a risk of chemical or biological hazards that require treatment and disposal. Increase the amount. In addition, manual sample collection into the fluid collection device is not only at risk of exposure, but also takes the hands of an engineer who can take other important tasks such as patient care, statistics input or other office work. Keep away from.

  Thus, there is a clear need for an improved system or method or apparatus useful in performing the task of dispensing a sample into a fluid collection device that minimizes the risk of exposure and frees up technician time.

In one embodiment of the invention, a port device or system is provided, for example, for sample introduction into a fluid collection device, the port device or system comprising:
(A) a first portion, (b) a second portion, (c) a third portion, and (d) a base,
(A) The first portion having a trapezoidal conical shape has a first end with an inner diameter A and a second end with an inner diameter B, where B is less than A;
(B) The second portion includes a first end portion with an inner diameter C, a second end portion with an inner diameter D, a longitudinal axis extending from the first end portion to the second end portion, and a substantial portion along the longitudinal axis. An annular inner surface, C is less than B, D is greater than C, and the first end of the second portion is in fluid communication with the second end of the first portion;
(C) The third portion includes a first end portion having an inner diameter E, a second end portion having an inner diameter F, a longitudinal axis extending from the first end portion to the second end portion, and a substantial portion along the longitudinal axis. An annular inner surface, E is less than C, F is greater than E, and the first end of the third portion is in fluid communication with the second end of the second portion;
(D) The base has a first end and a second end with an inner diameter G, G is less than E, and the first end of the base is fluidic with the second end of the third portion. Communicate.

  In one embodiment of the present invention, the first portion of such a port device or system is configured to receive and substantially seal the outer surface of the tip of the device having an outer diameter that is greater than B and less than A. Has been.

  In one embodiment of the invention, the second portion of such a port device or system is configured to receive and substantially seal the outer surface of a hollow tube having an outer diameter that is greater than or equal to C and less than D. ing.

  In one embodiment of the invention, the third portion of such a port device or system is adapted to receive and substantially seal the outer surface of a hollow tube having an outer diameter that is greater than or equal to E and less than C and less than F. It is configured.

In one embodiment of the present invention, for example, a port device or system for sample introduction into a fluid collection device is provided, the port device or system comprising a wall,
The wall is annular along the length, is composed of an elastomeric material, has a first end having a first end inner diameter, and a second end having a second end inner diameter;
The wall has an inner surface that defines at least a first sealing point portion having a first sealing point portion inner diameter and a second sealing point portion having a second sealing point portion inner diameter, and each sealing point end portion Are provided at a distance between the first end and the second end,
The second sealing point is located between the first sealing point and the second end,
The wall further has an intermediate inner diameter at an intermediate position between the first sealing point and the second sealing point,
The first sealing point portion inner diameter is less than the first end inner diameter and the intermediate inner diameter;
The second sealing point portion inner diameter is less than the intermediate inner diameter, less than the first end inner diameter and less than the second end inner diameter.

  In one embodiment of the present invention, a method for dispensing fluid is provided, the method comprising using a microfluidic test device as described above and containing fluid until substantially sealed. Inserting the device into the sample port and transferring the fluid between the first and second layers in the microfluidic test device via the open inlet port. The fluid collection device can be used in medical settings, eg, patient care / patient settings, research settings, and the like. The fluid may be a liquid or a gas.

  In one embodiment of the invention, a device or system as described above is in fluid communication with the open inlet port of the fluid collection device.

FIG. 2 shows a cross-sectional view of a sample introduction port associated with a fluid collection device shown by an example as a microfluidic test device. FIG. 4 shows a cross-sectional view of a sample introduction port associated with a fluid collection device, shown by way of example as a microfluidic test device, also showing insertion into the port at the tip of the device. Sectional view of a sample introduction port associated with a fluid collection device, shown by way of example as a microfluidic test device, also showing insertion of the tip of the syringe into a port where the screw thread of the syringe engages the tab of the port Indicates. FIG. 3 shows a cross-sectional view of a sample introduction port associated with a fluid collection device shown by an example as a microfluidic test device and also showing insertion of a hollow tube into the port. FIG. 3 shows a cross-sectional view of a sample introduction port associated with a fluid collection device shown by an example as a microfluidic test device and also showing insertion of a hollow tube into the port. FIG. 6 shows a cross-sectional view of a sample introduction port shown by an example as a microfluidic test device and associated with a fluid collection device. 1 is a schematic diagram illustrating a sample acquisition system and apparatus for acquiring a blood sample from a vein. 1 is a schematic diagram illustrating a sample acquisition system and apparatus for acquiring a blood sample from a vein. 3B is a schematic diagram illustrating insertion of a test tube / tube luer adapter from the sample acquisition system of FIGS. 3A and 3B into the sample introduction port of FIG. 1A. FIG. FIG. 3 is a schematic diagram showing insertion of a test tube / tube luer adapter from the sample acquisition system of FIGS. 3A and 3B into the sample introduction port of FIG.

  Before describing in detail at least one embodiment of the present invention, the present invention has been described in the following description or illustrated in the drawings with application to configuration details, component placement or processing step details. It should be understood that they are not limited in order. The invention is capable of other embodiments or of being practiced or carried out in various ways.

  Also, the terms and descriptions used herein are for illustrative purposes and should not be considered limiting.

  The present invention relates to sample introduction systems (hereinafter "ports") including various sample introduction devices, such as, but not limited to, various sized hollow tubes, syringes, test tube luer adapters, and the like. The port is useful for transferring a fluid sample to a fluid collection device, which is connected to an open port as part of or in such a fluid collection device. As such, multi- or single-use medical diagnostic devices, such as, but not limited to, blood gas, hematology or urine analysis systems or microfluidic devices. The fluid collection device may be selected from the group consisting of a multiple or single use blood gas test device or a microfluidic test device. The port is fixedly or removably attached to the fluid collection device, eg, at an angle sufficient to transfer fluid to the fluid collection device, eg, perpendicular to the surface of the fluid collection device. In the case of a microfluidic device, the port can be secured to the top or side of the fluid collection device. For example, the port is (1) welded to the fluid collection device, for example by ultrasonic welding, (2) mechanically connected to the fluid collection device, for example by one or more threads, and (3) to the fluid collection device, For example, they are bonded by adhesion or adhesion, and (4) they are fixed by a combination thereof. The fluid sample may be any biological and / or medical fluid that can be tested and / or sampled using a fluid collection device. For example, the fluid sample is selected from the group consisting of saliva, sputum, urine, cerebrospinal fluid, pleural fluid, dialysate, and combinations thereof. In one embodiment, the port can be used to transfer both blood (eg, for measuring HbA1C) and urine (eg, for measuring albumin / creatinine) to a fluid collection device.

  The port, for example, has, consists of, or substantially consists of at least one part capable of receiving a fluid containment device, more preferably a first part, a second part, a third part and a base. Become.

  The first portion preferably has, consists of, or substantially consists of a first end with an inner diameter A and a second end with an inner diameter B. However, B is less than A. The inner diameter A is about 2 mm or more and about 6 mm or less, more preferably about 3 mm or more and about 5 mm or less. The inner diameter B is about 2 mm or more and about 6 mm or less, more preferably about 3 mm or more and about 5 mm or less.

  The second portion includes a first end with an inner diameter C, a second end with an inner diameter D, a longitudinal axis extending from the first end to the second end, and a substantially annular inner surface along the longitudinal axis. , Or consist of these, or consist essentially of these. Preferably, C is less than B, D is greater than C, and the first end of the second portion is in fluid communication with the second end of the first portion. The advantages of having an inner diameter D greater than the inner diameter C tend to be (1) provide tactile response to the user when mounting the hollow tube in the port, and (2) if D is not greater than C. However, the hollow tube is prevented from being unintentionally pushed out of the port. The inner diameter C is about 2 mm or more and about 6 mm or less, preferably about 2 mm or more and about 5 mm or less. The inner diameter D is about 2 mm or more and about 6 mm or less, preferably about 3 mm or more and about 5 mm or less.

  The third portion has a first end with an inner diameter E, a second end with an inner diameter F, a longitudinal axis extending from the first end to the second end, and an annular inner surface along the longitudinal axis. Consisting of these, or substantially consisting of these. Preferably, E is less than C, F is greater than E, and the first end of the third portion is in fluid communication with the second end of the second portion. The advantages of having an inner diameter F greater than the inner diameter E are (1) providing tactile response to the user when mounting the hollow tube in the port, and (2) if F is not greater than E. However, the hollow tube is prevented from being unintentionally pushed out of the port. The inner diameter E is about 1 mm or more and about 4 mm or less, preferably about 1 mm or more and about 3.5 mm or less. The inner diameter F is about 1 mm or more and about 4.5 mm or less, and preferably about 1 mm or more and about 4 mm or less.

  The base has a first end with a diameter G and a second end, consists of, or substantially consists of these. Preferably, G is less than E and the first end of the base is in fluid communication with the second end of the third portion. The inner diameter G is about 0.1 mm or more and about 3 mm or less, and preferably about 0.2 mm or more and about 1.5 mm or less.

  The port further comprises a transition located between the second part and the third part. The transition has a first end having an inner diameter D and a second end having an inner diameter E, consists of or substantially consists of these. Preferably, the first end of the transition portion is in fluid communication with the second end of the second portion, and the second end of the transition portion is in fluid communication with the first end of the third portion. .

  The first portion, second portion, third portion, base and optional transition portion of the port may be in fluid communication with other portions by connection of adjacent portions, eg, by gluing, welding, fusing, and the like. By way of example, one or more parts are combined or otherwise attached as separate components to another one or more parts as one individual component. Similarly, the first part, the second part, the third part, the base and the optional transition part of the port are part of the solid unit along with such other adjacent parts so Can communicate. As an example of such, these portions are all part of a single molded or formed port, or are each part of a single molded or formed port.

  The second end of the base is in fluid communication with the open inlet port of the microfluidic test device. Such fluid communication may be due to the connection between the second end of the base and the open port, or the port and the microfluidic test device as multiple components of a single molded or formed unit. It may be in fluid communication. Preferably, the connection with the open inlet port at the second end of the base is a circumferentially sealed connection.

  The port is preferably composed of an elastomeric material, more preferably a thermoplastic elastomer such as KRATON® polymer material available from Kraton Polymers US LLC.

  The port is preferably configured to receive a fluid sample and pass the fluid sample through the microfluidic test device via an open inlet port. The first portion is configured to receive and substantially seal the outer surface of the tip of the device having an outer diameter that is greater than B and less than A. Such a device may be a syringe or test tube luer adapter and the tip is preferably substantially sealed at a location between the first and second ends of the first portion. .

  The second portion is configured to receive and substantially seal the outer surface of a hollow tube having an outer diameter greater than or equal to C and less than D. Preferably, the outer surface of the hollow tube is sealed at or near the first end of the second portion. Furthermore, the first end of the third portion has a smaller diameter than such a hollow tube, but can function as an ingress stop for such a hollow tube.

  Similarly, the third portion is configured to receive and substantially seal the outer surface of a hollow tube having an outer diameter greater than or equal to E and less than C and less than F. Preferably, the outer surface of the hollow tube is sealed at or near the first end of the third portion. Furthermore, the first end of the base is smaller in diameter than such a hollow tube and can function as an ingress stop for such a hollow tube.

  The first end of the first portion may further include an outer surface provided with at least two tabs. Such a tab is preferably configured to engage at least one threaded portion of the syringe to lock the syringe to the first end of the first portion. The threaded portion of the syringe can be engaged by screwing it into the tab and is secured in the correct position of the syringe.

  The second part and the third part may also have a trapezoidal conical shape.

  The port includes a sample port as described above, a first layer, a second layer located on the first layer and defining an open inlet port, and a component located between the first layer and the second layer. May comprise, consist of, or be part of a microfluidic test device consisting essentially of these. Components include, but are not limited to, pumps, chambers, capillaries, reagents, analyzers, and combinations thereof. The second end of the base of the sample port is in fluid communication with the open inlet port defined by the second layer.

  In addition, the present invention includes a method for sorting fluid, which method is substantially sealed with the step of using the microfluidic test device described above or another fluid collection device having a sample port as described above. Until a fluid containing device containing fluid is inserted into the sample port and through the open inlet port, the fluid is transferred to a position between the first layer and the second layer in the microfluidic test device. Steps, comprising, or consisting essentially of. If the fluid containment device is a syringe or test tube luer adapter, or some other such device having a tip having an outer diameter greater than B and less than A, the outer surface of the tip is within the second portion upon insertion. Sealed.

  The fluid storage device may be a hollow tube having an outer diameter of C or less and less than D. Upon insertion, the outer surface of such a hollow tube is sealed within the second portion at a position at or near the first end of the second portion.

  The fluid storage device may be a hollow tube having an outer diameter that is greater than or equal to E, less than C, and less than F. Upon insertion, the outer surface of such a hollow tube is sealed within the third portion at a position at or near the first end of the third portion.

  One embodiment of the present invention is described below with reference to FIGS.

  Referring to FIG. 1A, the figure shows a cross-sectional view of a sample introduction port 10 connected to a microfluidic test device 132 or a portion thereof.

  The trapezoidal cone-shaped first portion 102 includes a first end 104 having an inner diameter A and a second end 106 having an inner diameter B, where B is less than A.

  The second portion 108 includes a first end having an inner diameter C, a second end 112 having an inner diameter D, a longitudinal axis 114 extending from the first end 110 to the second end 112, and substantially along the longitudinal axis 114. And C is less than B, D is greater than C, and the first end 110 of the second portion 108 is in fluid communication with the second end 106 of the first portion 102. doing.

  The third portion 118 includes a first end 120 having an inner diameter E, a second end 122 having an inner diameter F, the same longitudinal axis 114 extending from the first end 120 to the second end 122, and the longitudinal axis 114. A substantially annular inner surface 116, wherein E is less than C, F is greater than E, and the first end 120 of the third portion 118 is in fluid communication with the second end 112 of the second portion 108. doing.

  The base 124 includes a first portion 126 having a diameter G and a second end 128, where G is less than E and the first end 126 of the base 124 is fluid with the second end 122 of the third portion 118. Communicate.

  The second end 128 of the base 124 is in fluid communication with the open inlet port 130 of the microfluidic test device 132. The port 10 also includes a transition having a first end 134 a with an inner diameter D and a second end 134 b with an inner diameter E, located between the second portion 108 and the third portion 118, and a transition portion 134. The first end 134 a of the second portion 108 is in fluid communication with the second end 112 of the second portion 108, and the second end 134 b of the transition portion 134 is in fluid communication with the first end 120 of the third portion 118. .

  The first end 104 of the first portion 102 has an outer surface 136 provided with at least two tabs 138. Further, the microfluidic test device 132 may have a capillary or channel or chamber 140.

  Referring to FIG. 1B, the figure shows a cross-sectional view of a sample introduction port connected to the microfluidic test device of FIG. 1A and also shows the insertion of the tip of the device into the port.

  The first portion 102 is configured to receive and substantially seal the outer surface 142 of the tip of the device 144 and the outer diameter of the tip of the device 144 is greater than B and less than A. The tip of the device 144 may be tapered as shown and is considered a portion that is acceptable by the first portion 102.

  Referring to FIG. 1C, the figure shows a cross-sectional view of the sample introduction port 10 connected to the microfluidic test device of FIG. 1A, with the port at the tip of the syringe 144 with the syringe 146 engaged with the tab 138. 10 further illustrates insertion.

  Referring to FIG. 1D, the figure shows a cross-sectional view of the sample introduction port 10 connected to the microfluidic test apparatus of FIG. 1A, and also shows insertion into the port 10 of the hollow tube.

  The second portion 108 is configured to receive and substantially seal the outer surface 148 of the hollow tube 150 having an outer diameter that is greater than or equal to C and less than D. The outer surface 148 of the hollow tube 150 is sealed at or near the first end 110 of the second portion 108. The first end 120 of the third portion 118 can function as an ingress stop for the hollow tube 150. The advantages of having an inner diameter D greater than the inner diameter C tend to be (1) provide tactile response to the user when mounting the hollow tube in the port, and (2) if D is not greater than C. However, the hollow tube is prevented from being unintentionally pushed out of the port.

  Referring to FIG. 1E, the figure shows a cross-sectional view of the sample introduction port 10 connected to the microfluidic test device of the device 1A, and also shows the insertion into the port 10 of the hollow tube.

  The third portion 118 is configured to receive and substantially seal the outer surface 152 of the hollow tube 154 having an outer diameter greater than or equal to E and less than C and less than F. The outer surface 152 of the hollow tube 154 is sealed at or near the first end 120 of the third portion 118. The first end 126 of the base 124 can function as an ingress stop for the hollow tube 154. The advantages of having an inner diameter F greater than the inner diameter E are (1) tactile response to the user when mounting the hollow tube 154 in the port, and (2) when F is not greater than E. Often, the hollow tube 154 is prevented from being unintentionally pushed out of the port.

  Although not shown, it should be understood that a hollow tube having an outer diameter of G or less can be inserted into the base 124. Further, with reference to FIG. 1A, it should be understood that a hollow tube having an outer diameter that is less than or equal to the outer diameter of the open inlet port 130 can be inserted into the open inlet port 130.

  Referring to FIG. 2, there is shown a cross-sectional view of a sample introduction port 20 showing another embodiment of the present invention.

  The wall 202 is annular along its length and has a first end 204 having a first end inner diameter 206 and a second end 208 having a second end inner diameter 210. The wall 202 can be composed of an elastomeric material, preferably a thermoplastic elastomer. The wall 202 includes an inner surface 212 that defines a first sealing point portion 214 having a first sealing point portion inner diameter 216 and a second sealing point portion 218 having a second sealing point portion inner diameter 220. The first sealing point portion 214 and the second sealing point portion 218 are located apart between the first end portion 204 and the second end portion 208. The second sealing point portion 218 is located between the first sealing point portion 214 and the second end portion 208. The wall 202 further has an intermediate inner diameter 222 at a position intermediate between the first sealing point 214 and the second sealing point 218. The first sealing point inner diameter 216 is less than the first end inner diameter 206 and less than the intermediate inner diameter 222. The second sealing point portion inner diameter 220 is less than the intermediate inner diameter 222, less than the first sealing point portion inner diameter 216, and less than the second end portion inner diameter 210.

  The second end 208 of the port 20 can be in fluid communication with the open inlet port 224 of the microfluidic test device 226. Such fluid communication is possible by connecting the second end 208 to the open inlet port 224, preferably as a circumferential sealed connection, as described above. Second end 208 and microfluidic test device 226 may each be part of a single molded or formed unit.

  Port 20 is configured to receive a fluid sample and pass the fluid sample through microfluidic test device 226 via open inlet port 224.

  The first end inner diameter 206 may be about 2 mm or more and about 6 mm or less, more preferably about 3 mm or more and about 5 mm or less. The second end inner diameter 210 may be about 1 mm to about 4.5 mm, more preferably 1 mm to about 4 mm.

  The first sealing point portion inner diameter 216 is about 2 or more and about 6 mm or less, preferably about 2 mm or more and about 5 mm or less.

  The second sealing point portion inner diameter 220 is about 1 mm or more and about 4 mm or less, more preferably about 1 mm or more and about 3.5 mm or less.

  The intermediate inner diameter 222 is about 2 mm or more and about 6 mm or less, more preferably about 3 mm or more and about 5 mm or less.

  The port 20 is configured to receive and substantially seal the outer diameter of the tip of the device, the tip of the device being larger than the first sealing point inner diameter 216 and less than the first end inner diameter 206. . The tip of such a device may be tapered as shown and is considered a portion that port 20 can accept. Such devices are, for example, but not limited to syringes or test tube luer adapters.

  The port 20 is further configured to receive and substantially seal the outer surface of a hollow tube having an outer diameter that is greater than or equal to the first sealing point inner diameter 216 and less than the first end inner diameter 206. The outer surface of the hollow tube is preferably sealed at or near the first sealing point 214, and the second sealing point 218 can function as an ingress stop for the hollow tube. The advantages of having a first sealing point inner diameter 216 that is less than the intermediate inner diameter 222 are (1) providing a tactile response to the user when mounting the hollow tube in the port 20, and (2) the first This is often the case when the inner diameter 216 of one sealing point is greater than or equal to the intermediate inner diameter 222, but the hollow tube is prevented from being unintentionally pushed out of the port 20.

  The port 20 further receives an outer surface of a hollow tube having an outer diameter that is greater than or equal to the second sealing point inner diameter 220, less than the first sealing point inner diameter 216, and less than the second end inner diameter 210, substantially It is comprised so that it may seal. The outer surface of such a hollow tube is preferably sealed at or near the second sealing point 218. The advantages of having a second sealing point inner diameter 220 less than the second end inner diameter 210 are (1) providing a tactile response to the user when mounting the hollow tube in the port 20, and ( 2) This is often the case when the second sealing point inner diameter 220 is equal to or larger than the second end inner diameter 210, but the hollow tube is prevented from being unintentionally pushed out of the port 20.

  It should be understood that a hollow tube having an outer diameter that is less than or equal to the diameter of the open inlet port 224 may be inserted into the open inlet port 224.

  The first end 204 of the wall 202 may further have an outer surface 228 provided with at least two tabs 230. Tab 230 is configured to engage at least one threaded portion of the syringe to lock the syringe to the first end of the wall (as described with respect to FIG. 1C).

  Referring to FIGS. 3A-3C, the figures illustrate a method for collecting a blood sample and sending it to a microfluidic test device.

  Referring to FIG. 3A, there is shown a schematic diagram illustrating a sample acquisition system and apparatus for acquiring a blood sample from a vein.

  The method includes a venous needle 300; a tube 302 having a first end 304 and a second end 306; a male luer 310, which may be tapered as shown, and a hollow needle in fluid communication with the male luer 310. A test tube luer adapter 308 having a female luer 312 having 314; a test tube 316 having an open end 318 sealed with an elastomeric sealing member 320, by the test tube 316 and the elastomeric sealing member 320; A test tube 316 in which a space 320 of less than atmospheric pressure, preferably less than 1 atmosphere is defined, consists of or consists essentially of these.

  The venous needle 300 is connected in fluid communication with the first end 304 of the tube 302 and the second end 306 of the tube 302 is connected in fluid communication with the male luer 310 of the test tube luer adapter 308. The system may further include a connector 324 having a first end 326 and a second end 328, where the first end 326 of the connector 324 is connected in fluid communication with the second end 306 of the tube 302. The second end 328 of 324 is connected in fluid communication with the male luer 310, thereby establishing fluid communication between the second end 306 of the tube 302 and the male luer 310.

  The venous needle 300 is inserted into a vein containing blood and a path for blood flowing from the vein to the test tube luer adapter 308 is established.

  Referring to FIG. 3B, the test tube 316 is inserted into the female luer 312 of the test tube luer adapter 308, thereby forming a hole through the elastomeric sealing member 320 by the hollow needle 314, thereby creating a vein. Blood is drawn into the space 322 of the test tube 316. The second end 306 of the tube 302 (or the second end 328 of the connector 324, if used) is removed from the male luer 310.

  Referring to FIGS. 3C and 3D, a male luer 310 is then inserted into the sample introduction port described above.

  As shown in FIG. 3C, the male luer 310 is inserted into the first portion 102 of the sample port 10 until it is substantially sealed within the first portion 102. The blood is then transferred from the space 322 via the open inlet port 130 into the microfluidic test device 132.

  As shown in FIG. 3D, the male luer 310 is substantially sealed through the first end 204 at a location between the first end 204 and the first sealing point 214. It is inserted into the port 20. Blood is transferred from space 322 into microfluidic test device 226 via open inlet port 224.

  Unless clearly indicated to the contrary, “or / or / or” means non-exclusive “or / or / or” and does not mean exclusive “or / or / or”. For example, the condition “A or B” is satisfied by any of the following: A is true (or present), B is false (or absent); A is false (or absent), and B is true (Or present); and A and B are true (present).

  Also, unless stated otherwise, the term “about” as used herein includes and accounts for changes due to manufacturing tolerances and / or variations in process control.

  Changes may be made in the arrangement and operation of various components, elements and assemblies described herein without departing from the spirit and scope of the invention as set forth in the appended claims. Variations can be made in the method steps and order of steps described herein.

Claims (58)

A port comprising: (a) a first part; (b) a second part; (c) a third part; and (d) a base.
(A) The first portion having a trapezoidal cone shape has a first end portion having an inner diameter A and a second end portion having an inner diameter B, and B is less than A;
(B) The second portion has a first end with an inner diameter C, a second end with an inner diameter D, a longitudinal axis extending from the first end to the second end, and along the longitudinal axis. And C is less than B, D is greater than C, and the first end of the second portion is in fluid communication with the second end of the first portion. And
(C) The third portion has a first end with an inner diameter E, a second end with an inner diameter F, a longitudinal axis extending from the first end to the second end, and the longitudinal axis. And E is less than C, F is greater than E, and the first end of the third portion is in fluid communication with the second end of the second portion. And
(D) The base has a first end and a second end with an inner diameter G, G is less than E, and the first end of the base is the first of the third portion. In fluid communication with the two ends,
The first portion is configured to receive and substantially seal the outer surface of the tip of the device having an outer diameter greater than B and less than A from the first end of the inner diameter A;
The second portion is configured to receive and substantially seal the outer surface of the tip of the device having an outer diameter that is greater than or equal to C and less than D;
The third portion is configured to receive and substantially seal the outer surface of the tip of the device having an outer diameter that is greater than or equal to E and less than C and less than F;
A port characterized by that.   The port of claim 1, wherein the second end of the base is in fluid communication with an open inlet port of a fluid collection device selected from the group consisting of a microfluidic test device and a single-use or multi-use test device. .   The port of claim 2, wherein the fluid collection device is a microfluidic test device.   The port of claim 2, wherein the fluid collection device is a medical diagnostic test device.   The port of claim 2, wherein the second end of the base is connected in fluid communication with the open inlet port in a fixed or removable manner.   The port of claim 5, wherein the connection of the second end of the base to the open inlet port is a circumferentially sealed connection.   The port of claim 2, wherein the port is configured to receive a fluid sample and pass the fluid sample through the open inlet port to the microfluidic test device.   The port of claim 1, wherein the port is composed of an elastomeric material.   The port of claim 8, wherein the elastomeric material is a thermoplastic elastomer.   The port according to claim 1, wherein the inner diameter A is about 2 mm or more and about 6 mm or less.   The port according to claim 10, wherein the inner diameter A is about 3 mm or more and about 5 mm or less.   The port according to claim 10, wherein the inner diameter B is about 2 mm or more and about 6 mm or less.   The port according to claim 12, wherein the inner diameter B is about 3 mm or more and about 5 mm or less.   The port according to claim 12, wherein the inner diameter C is about 2 mm or more and about 6 mm or less.   The port according to claim 14, wherein the inner diameter C is about 2 mm or more and about 5 mm or less.   The port of claim 14, wherein the inner diameter D is about 2 mm or more and about 6 mm or less.   The port according to claim 16, wherein the inner diameter D is about 3 mm or more and about 5 mm or less.   The port according to claim 16, wherein the inner diameter E is about 1 mm or more and about 4 mm or less.   The port of claim 18, wherein the inner diameter E is between about 1 mm and about 3.5 mm.   The port of claim 18, wherein the inner diameter F is between about 1 mm and about 4.5 mm.   21. The port of claim 20, wherein the inner diameter F is about 1 mm or more and about 4 mm or less.   21. The port of claim 20, wherein the inner diameter G is between about 0.1 mm and about 3 mm.   23. The port of claim 22, wherein the inner diameter G is between about 0.2 mm and about 1.5 mm.   The port of claim 1, wherein the device is a hollow tube, syringe or test tube luer adapter.   The port of claim 1, wherein the tip is substantially sealed at a location between the first end and the second end of the first portion.   The port of claim 1, wherein the outer surface of the device is sealed at or near the first portion of the second portion.   27. The port of claim 26, wherein the first end of the third portion serves as an ingress stop for the device.   The port of claim 1, wherein the outer surface of the device is sealed at or near the first end of the third portion.   29. The port of claim 28, wherein the first end of the base serves as an ingress stop for the device. A transition portion located between the third portion and the second portion and having a first end with an inner diameter D and a second end with an inner diameter E;
The first end of the transition portion is in fluid communication with the second end of the second portion;
The second end of the transition portion is in fluid communication with the first end of the third portion;
The port according to claim 1. The first end of the first portion further comprises an outer surface provided with at least two tabs;
The port of claim 1, wherein the tab is configured to engage at least one threaded portion of a syringe and lock the syringe to the first end of the first portion.   The port of claim 1, wherein the second portion has a trapezoidal cone shape.   The port of claim 1, wherein the third portion has a trapezoidal cone shape. A microfluidic testing device comprising:
(A) having a first layer;
(B) having a second layer provided on a different surface than the first layer and defining an open inlet port;
(C) having a component located between the first layer and the second layer, wherein the component is from the group consisting of pumps, chambers, capillaries, reagents, analyzers and combinations thereof Selected
(D) having a sample port, provided that the sample port comprises (i) a first part, (ii) a second part, (iii) a third part, and (iv) a base part. And
(I) The first portion having a trapezoidal cone shape has a first end portion having an inner diameter A and a second end portion having an inner diameter B, and B is less than A.
(Ii) The second portion includes a first end having an inner diameter C, a second end having an inner diameter D, a longitudinal axis extending from the first end to the second end, and the longitudinal axis. And C is less than B, D is greater than C, and the first end of the second portion is in fluid communication with the second end of the first portion. And
(Iii) The third portion extends along the longitudinal axis, a first end portion having an inner diameter E, a second end portion having an inner diameter F, a longitudinal axis extending from the first end portion to the second end portion, and And E is less than C, F is greater than E, and the first end of the third portion is in fluid communication with the second end of the second portion. And
(Iv) The base has a first end and a second end with an inner diameter G, G is less than E, and the first end of the base is the first of the third portion. In fluid communication with the two ends,
(E) the second end of the base of the sample port is in fluid communication with the open inlet port;
The first portion is configured to receive and substantially seal the outer surface of the tip of the device having an outer diameter greater than B and less than A from the first end of the inner diameter A;
The second portion is configured to receive and substantially seal the outer surface of the tip of the device having an outer diameter that is greater than or equal to C and less than D;
The third portion is configured to receive and substantially seal the outer surface of the tip of the device having an outer diameter that is greater than or equal to E and less than C and less than F;
A microfluidic test apparatus characterized by the above. A method for separating fluid,
(A) using the microfluidic test device of claim 34;
(B) inserting a fluid containment device for containing fluid into the sample port until substantially sealed;
(C) transferring the fluid between the first layer and the second layer in the microfluidic test device via the open inlet port;
Including a method.   The fluid containment device is a hollow tube, syringe, or test tube luer adapter having a tip having an outer diameter greater than B and less than A, the outer surface of the tip being subjected to insertion in step (b) 36. The method of claim 35, wherein the method is sealed within the first portion.   The fluid containment device is a syringe, and the first end of the first portion further comprises an outer surface provided with at least two tabs configured to engage at least one threaded portion of the syringe. 38. The method of claim 36, wherein the threaded portion of the syringe is engaged by screwing against the tab to lock the syringe to the first end of the first portion.   The fluid storage device is a device having an outer diameter that is greater than or equal to C and less than D, and the outer surface of the device is at or near the first end of the second portion when inserted in step (b). 36. The method of claim 35, wherein the method is sealed within the second portion.   The fluid storage device is a device having an outer diameter that is greater than or equal to E and less than C and less than F, and the outer surface of the device is the first end of the third portion or the third portion when inserted in step (b) 36. The method of claim 35, wherein the method is sealed within the third portion in the vicinity thereof. A port with walls,
The wall is annular along the length and is composed of an elastomeric material and has a first end having a first end inner diameter and a second end having a second end inner diameter;
The wall has an inner surface defining at least a first sealing point portion having a first sealing point portion inner diameter and a second sealing point portion having a second sealing point portion inner diameter; The portions are provided at a distance from each other between the first end and the second end,
The second sealing point is located between the first sealing point and the second end;
The wall further has an intermediate inner diameter at an intermediate position between the first sealing point and the second sealing point;
The first sealing point inner diameter is less than the first end inner diameter and less than the intermediate inner diameter;
The second sealing point inner diameter is less than the intermediate inner diameter, less than the first end inner diameter and less than the second end inner diameter;
The port is configured to receive and substantially seal the outer surface of the tip of the device having an outer diameter greater than the inner diameter of the first sealing point and less than the inner diameter of the first end from the first end. And
The port receives and substantially seals the outer surface of the tip of the device having an outer diameter that is greater than or equal to the second sealing point inner diameter, less than the first sealing point inner diameter, and less than the second end inner diameter. Configured to
A port characterized by that.   41. The fluid port of claim 40, wherein the second end of the port is in fluid communication with an open inlet port of a fluid collection device selected from the group consisting of a microfluidic test device and a multiple or single use medical diagnostic device. port.   42. The port of claim 41, wherein the fluid collection device is a microfluidic test device.   42. The port of claim 41, wherein the fluid collection device is a blood gas test device.   42. The port of claim 41, wherein the second end is connected in fluid communication with the open inlet port in a fixed or removable manner.   45. The port of claim 44, wherein the connection of the second end with the open inlet port is a circumferentially sealed connection.   42. The port of claim 41, wherein the port is configured to receive a fluid sample and pass the fluid sample through the open inlet port to the fluid collection device.   41. The port of claim 40, wherein the port is composed of an elastomeric material.   48. The port of claim 47, wherein the elastomeric material is a thermoplastic elastomer.   41. The port of claim 40, wherein the first end inner diameter is between about 2 mm and about 6 mm.   41. The port of claim 40, wherein the inner diameter of the second end is not less than about 1 mm and not more than about 4.5 mm.   41. The port of claim 40, wherein the inner diameter of the first sealing point portion is about 2 mm or more and less than about 6 mm.   41. The port according to claim 40, wherein the inner diameter of the second sealing point part is not less than about 1 mm and not more than about 4 mm.   41. The port of claim 40, wherein the intermediate inner diameter is between about 2 mm and about 6 mm.   41. The port of claim 40, wherein the device is a hollow tube, syringe or test tube luer adapter.   41. The port of claim 40, wherein the outer surface of the device is sealed at or near the first sealing point.   56. The port of claim 55, wherein the second sealing point functions as an ingress stop for the device. 41. The port of claim 40 , wherein the outer surface of the device is sealed at or near the second sealing point. The first end of the wall further comprises an outer surface provided with at least two tabs;
41. The port of claim 40, wherein the tab is configured to engage at least one threaded portion of a syringe and lock the syringe to the first end of the wall.

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